MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. DRAGONFLY¿ OPTIS¿; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	C408646
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and additional analysis methods were performed on the returned device.The reported communication issue was unable to be confirmed due to the condition of the returned device (dried contrast throughout sheath and deformed sheath) which prevented functional testing.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot of specific issue.The investigation was unable to determine the cause for the reported communication issue.The returned catheter was unable to be functionally tested, however, the optical fiber of the returned catheter was confirmed to have remained intact.There were no damages, nor anomalies which could be attributed to the reported communication issue.In this case, it is likely that the signal of the catheter¿s radio-frequency identification device (rfid) was intermittently inhibited by liquid exposure (wet gloves); however, this could not be confirmed.The observed deformation and subsequent tear in the window tube are consistent with over-pressurization of the catheter while the lumen is obstructed (observed dried contrast in sheath), and likely occurred after the reported communication issue as the damage would have been noticed when the purged liquid exited from the deformation site.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure the dragonfly optis imaging catheter was prepared; however, the device was not recognized by the system.The device was disconnected and reconnected but had the same issue.The procedure was completed without imaging.There was no patient involvement and there was no clinically significant delay in the procedure.Returned device analysis identified that the catheter was returned with the sheath and window tube twisted, resulting in a tear and twisting in the window tube material at the splice region.No additional information was provided.

• Brand Name: DRAGONFLY¿ OPTIS¿
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20472776
• Report Number: 2024168-2024-12249
• Device Sequence Number: 15342354
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250705(10)9124003
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2025
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 9124003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male